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U.S. Department of Health and Human Services

Medical Device Recalls
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Related Medical Device Recalls
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Z-0506-2026 - Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 106531US, HeartMate 3 Controller, US; 106531INT, HeartMate 3 Controller, OUS; 106531LF2, HeartMate 3 Low... 2 11/14/2025 Thoratec LLC
Z-0505-2026 - Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US, HeartMate 3 LVAS KIT, US; 106524INT, HeartMate 3 LVAD KIT, OUS; 106524 Software V... 2 11/14/2025 Thoratec LLC
Z-0508-2026 - Brand Name: HeartMate Product Name: HeartMate II® Controller (standalone) Model/Catalog Number: 106017, HeartMate II® Pocket Controller, US; 106762, HeartMate II® Pocket Controller, US; 107801, Hear... 2 11/14/2025 Thoratec LLC
Z-0507-2026 - Brand Name: HeartMate Product Name: HeartMate II® LVAS Implant Kit Model/Catalog Number: 106015, HeartMate II® LVAS Kit, with Pocket Controller, Sealed, US; 106016, HeartMate II® LVAS Kit, with Pock... 2 11/14/2025 Thoratec LLC
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